Trial record 71 of 243 for: "Viral Infectious Disease" | "Lopinavir"
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects (HIV)
|ClinicalTrials.gov Identifier: NCT00654147|
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : July 13, 2015
Last Update Posted : August 3, 2015
Margaret A. Fischl, M.D.
Information provided by (Responsible Party):
Margaret A. Fischl, M.D., University of Miami
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Drug: Raltegravir & Lopinavir/ritonavir
Drug: Raltegravir and emtricitabine/tenofovir
|Recruitment Details||Patients were randomly assigned to receive one of two regimens Raltegravir (Isentress, Merck & Company) 400 mg twice daily with either Lopinavir/ritonavir (Kaletra, Abbott Laboratories) 200 mg/100 mg twice daily or with emtricitabine/tenofovir (Truvada, Gilead Sciences) 200 mg/100 mg twice daily.|
|Pre-assignment Details||Participants with acute or recent HIV-1 infection, major resistance-associated mutation on any genotype performed at any time prior to study entry, serious illness requiring systemic treatment and/or hospitalization within 7 days of study entry, HBsAg positivity, acute hepatitis of any etiology, clinically significant liver disease were excluded|
Pilot study with 44 subjects and generalization f results is limited by the small sample size.